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Studies

Interventional Active not recruiting Phase 3

NCT03496883 on ClinicalTrials.gov

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

Official title: Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

  • Sponsor: Joseph Broderick, MD
  • Collaborators: Novo Nordisk A/S, National Institute of Neurological Disorders and Stroke (NINDS)
  • Enrollment: 860 (Estimated)
  • Study start: 2021-12-03 (Actual)
  • Primary completion: 2028-01-01 (Estimated)
  • Study completion: 2028-01-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

Conditions

  • Intracerebral Hemorrhage

Intervention / Treatment

  • Biological: Recombinant Activated Factor VII (rFVIIa)
  • Biological: Placebo

Primary Outcome Measures

  • Modified Rankin Scale (mRS) (180 days)
    Ordinal distribution with the following steps: 0-2, 3, 4-6

Countries

Canada, Germany, Japan, Spain, United Kingdom, United States

Locations and Investigators

  • Hospital Universitari De Girona Doctor Josep Trueta, Girona, Spain
    • Yolanda, Silva Blas
  • Hospital Germans Trias I Pujol, Badalona, Spain
    • Alejandro, Bustamante Rangel
  • Hospital Clinico Universitario De Valladolid, Valladolid, Spain
    • Juan, Arenillas
  • Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida, Lleida, Spain
    • Francisco, Purroy
  • Hospital Universitari Joan XXIII De Tarragona, Tarragona, Spain
    • Xavier, Ustrell Roig
  • Hospital Universitari Vall D Hebron, Barcelona, Spain
    • Carlos, Molina
  • Bellvitge University Hospital, Barcelona, Spain
    • Pere, Cardona Portela
  • Hospital De La Santa Creu I Sant Pau, Barcelona, Spain
    • Anna, Ramos Pachón
  • Universitaetsklinikum Tuebingen AöR, Tuebingen, Germany
    • Annerose, Mengel
  • Universitaetsklinikum Erlangen AöR, Erlangen, Germany
  • Universitaetsklinikum Heidelberg AöR, Heidelberg, Germany
    • Jan, Purrucker
  • Universitaetsklinikum Leipzig AöR, Leipzig, Germany
    • Katja, Wartenberg
  • University Medical Center Hamburg-Eppendorf, Hamburg, Germany
    • Goetz, Thomalla
  • Klinikum Frankfurt Hoechst GmbH, Frankfurt Am Main, Germany
    • Thorsten, Steiner
  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden, Germany
    • Kristian, Barlinn
  • Charite Universitaetsmedizin Berlin KöR, Berlin, Germany
    • Jan, Scheitz
  • Universitaetsklinikum Augsburg, Augsburg, Germany
    • Hauke, Schneider

Study Officials